NCT04518527

Brief Summary

Lateral epicondylitis is a degenerative tendinosis of the extensor carpi radialis brevis muscle and is the most common work/sports-related chronic musculoskeletal problem affecting the elbow. This randomized, double-blinded, controlled study aimed to evaluate the short term and residual effectiveness of the Kinesio taping method on pain, grip force, quality of life, and functionality.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 19, 2020

Completed
Last Updated

August 19, 2020

Status Verified

February 1, 2017

Enrollment Period

3 months

First QC Date

August 12, 2020

Last Update Submit

August 14, 2020

Conditions

Keywords

Kinesio tapinglateral epicondylitisresidual effect

Outcome Measures

Primary Outcomes (1)

  • numerical rating scale

    The numerical rating scale (NRS) was used to evaluate the pain level of the patients included in the study. It is a one-dimensional scale consisting of 11 items that measure pain intensity in adults and is a segmented - intermittent numerical version of the visual analogue scale (VAS).

    1 year

Secondary Outcomes (4)

  • resisted muscle test evaluation

    1 year

  • Maximal Isometric Handgrip Strength

    1 year

  • The Patient-rated Tennis Elbow Evaluation(PRTEE)

    1 year

  • 36-Item Short-Form Health Survey (SF-36)

    1 year

Study Arms (2)

true taping+ exercise

ACTIVE COMPARATOR

The true taping method was applied to the first group according to the method determined by Kase. According to this method, a 2-inch (5 cm) wide beige-colored Kinesio tape (Kinesio® Tex Gold FP) was measured from the second-third metacarpal base to the lateral epicondyle while the elbow was extended and the wrist was in the neutral position and the tape was applied in the shape of a 'Y'. In a position where the wrist-ankle extensors were most tense (wrist-ankle extension - forearm pronation), the anchor point of the tape was applied to the insertion of the muscle without creating any tension. Then, the tape was applied to the medial and lateral edges of the wrist extensors by applying a 15-25% tension towards the origin of the muscle. Both ends of the Y-shaped tape were terminated without tension on the lateral epicondyle.

Device: Tape

sham taping+exercise

PLACEBO COMPARATOR

In the placebo group, the 10 cm I-shaped tape was placed 5 cm inferior to the lateral epicondyle using the same Kinesio tape in the study group. It was applied transversely, starting from the painless side of the midline on the forearm extensor face directing towards the lateral side of the forearm without a tension.

Device: Tape

Interventions

TapeDEVICE

The tape is an elastic cotton strip with an acrylic adhesive that is used with the intent of treating pain and disability

sham taping+exercisetrue taping+ exercise

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Having pain on or near the lateral epicondyle and increases with pain at least one of the following provocations tests for lateral epicondylitis -resisted wrist extension (Cozen's test), resisted elbow supination (Mill's test) and 3rd finger extension (Maudley's test),
  • Unilateral elbow pain at least 12 weeks,
  • Not received injection therapy to the elbow in the last six weeks,
  • Not received a physical therapy program in the last three months,
  • Presence of normal elbow radiographic findings,
  • Normal elbow joint range of motion,
  • Having no neurological deficits

You may not qualify if:

  • Patients with degenerative joint disease,
  • Radial tunnel syndrome,
  • Cervical nerve root compression,
  • Pain reflected from the neck, shoulders,
  • Wrist, radiohumeral joint osteochondritis dissecans,
  • Tendon rupture,
  • Osteoporosis, Infection,
  • Malignancy,
  • Inflammatory disease,
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Elbow TendinopathyTennis Elbow

Condition Hierarchy (Ancestors)

TendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Study Officials

  • IŞIL S YENİCE BALEVİ

    Gazi University

    PRINCIPAL INVESTIGATOR
  • BELGİN KARAOĞLAN

    Gazi University

    STUDY DIRECTOR
  • NAGİHAN ACET

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Prof

Study Record Dates

First Submitted

August 12, 2020

First Posted

August 19, 2020

Study Start

February 1, 2017

Primary Completion

May 1, 2017

Study Completion

July 1, 2017

Last Updated

August 19, 2020

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Locations